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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K250140
Device Name Defendo Fujifilm 700 Single Use Cleaning Adapter
Applicant
Steris Corparation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
Steris Corparation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number876.1500
Classification Product Code
ODC  
Date Received01/17/2025
Decision Date 02/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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